(22 days)
Not Found
No
The description details a chemical reaction and photometric measurement, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is a diagnostic reagent used for the quantitative determination of magnesium levels in bodily fluids, not for treating a condition.
Yes
The device is described as "intended for use for the quantitative determination of magnesium in human serum, plasma, and urine," which is a diagnostic purpose. It measures a biomarker (magnesium concentration) to provide information relevant for diagnosis.
No
The device is a reagent, which is a chemical substance used in a chemical reaction, not a software program. The description details a chemical process for determining magnesium concentration.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of magnesium in human serum, plasma, and urine". These are biological samples taken in vitro (outside the body).
- Device Description: The description details a chemical reaction that occurs with the sample in vitro to produce a measurable result.
- Automated Clinical Chemistry Analyzers: The device is intended for use on automated clinical chemistry analyzers, which are instruments used to perform tests on biological samples in vitro.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1495, a Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Product codes
JGJ
Device Description
Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an alkaline solution. Magnesium + xylidyl blue alkaline -> purple complex. EGTA in the reagent complexes with calcium, so that only magnesium reacts with the indicator. The intensity of the color of the purple complex formed is proportional to the magnesium concentration and can be measured photometrically.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance of the Roche Diagnostics Magnesium reagent is substantially equivalent to other products in commercial distribution intended for similar use.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.
0
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Boehringer Mannheim Corporation, dba Roche Diagnostics
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000
Contact Person: Luann Ochs
Date Prepared: September 18, 1998 |
| 2) Device name | Proprietary name: Roche Diagnostics Magnesium Reagent
Common name: magnesium test system
Classification name: photometric method, magnesium 75JGJ
Device Class I |
| 3) Predicate
device | We claim substantial equivalence to the currently marketed Roche
Diagnostics Magnesium reagent system, catalog number 804551,
manufactured by Bio-Analytical labs. K810084. |
| 4) Device
Description | Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an
alkaline solution.
Magnesium + xylidyl blue alkaline -> purple complex
EGTA in the reagent complexes with calcium, so that only magnesium reacts
with the indicator. The intensity of the color of the purple complex formed is
proportional to the magnesium concentration and can be measured
photometrically. |
1
510(k) Summary, Continued
| 5) Intended use | The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers. |
|---|---|
| 6) Comparison to predicate device | The Roche Diagnostics Magnesium reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics Magnesium reagent system, catalog number 804551, manufactured by Bio-Analytical Labs, K810084. |
The following table illustrates the similarities between the Roche Diagnostics Magnesium Reagent and the predicate device. Specific data on the
Magnesium Reagent and the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI.
| Feature | New Magnesium
Reagent | Predicate Magnesium
Reagent |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of
magnesium | Measurement of
magnesium |
| Sample Type | Serum, plasma, CSF,
no preparation required.
Urine, diluted with
0.9% saline or water | Serum, plasma, CSF,
no preparation required.
Urine, acidified to pH 1
prior to assay |
| Use on Automated
Chemistry Analyzers? | Yes | Yes |
| Test Principle | Magnesium is reacted
with xylidyl blue in an
alkaline solution, in the
presence of EGTA,
resulting color is
measured spectro-
photometrically | Magnesium is reacted
with calmagite in an
alkaline solution, in the
presence of EGTA and
KCN, resulting color is
measured spectro-
photometrically |
| Calibration | Two points, blank
(saline) and about 1.4
mmol/L (2.8
mEq/L)magnesium | Two points, blank
(saline) and about about
1.4 mmol/L (2.8
mEq/L)magnesium |
Similarities:
Continued on next page
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510(k) Summary, Continued
- Comparison to predicate device (continued)
| Feature | New Magnesium
Reagent | Predicate Magnesium
Reagent |
|-------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Calibration Stability | Perform a new
calibration with a bottle
or reagent lot change | Perform a new
calibration every 24
hours, and with a bottle
or reagent lot change |
| Kit Configuration,
Reagent Preparation | R1, liquid, ready-to-use
R2, liquid, ready-to-use | R1, liquid, ready-to-use
R2, liquid, ready-to-use |
| Reagent On-board
Stability | 3 weeks | 1 week |
Similarities:
6) Comparison Differences: to predicate
device,
continued
There are no significant differences between the Roche Diagnostics Magnesium reagent and the predicate device for purposes of considering substantial equivalence.
Performance characteristics:
The performance of the Roche Diagnostics Magnesium reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notabiy it is substantially equivalent to the currently marketed Roche Diagnostics Magnesium reagent system, catalog number 804551, manufactured by Bio-Analytical Labs, K810084.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 21 1998
Luann Ochs . Requlatory Program Manager Boehringer Mannheim Corporation, dba Roche Diagnostics 9115 Haque Road P.O. Box 50457 46250-0457 Indianapolis, Indiana
Re: K983416 Roche Diagnostics Magnesium Reagent Requlatory Class: I Product Code: JGJ Dated: September 18, 1998 Received: September 29, 1998
Dear Ms. Ochs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman.
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ..
5
K983416 510(k) Number (if known): Device Name: Roche Diagnostics Magnesium Reagent
Indications for Use:
The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1495, a Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). It is classified in Class I.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 983916